Cardiac Surgery SubjectsNCT06881212
Effects Of Therapeutic Approaches On Intubation Response, Agitation Behavior, And Extubation Time İn Patients Undergoing Open Heart Surgery
A study testing THERAPEUTIC APPROACH TRAINING in people with Cardiac Surgery Subjects and Nursing Care, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to understand how training given to patients before and after open-heart surgery affects their reactions during intubation (when a breathing tube is inserted), their agitation levels, and the time it takes to remove the breathing tube. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Cardiac Surgery Subjects, Nursing Care
- What is being tested?
- THERAPEUTIC APPROACH TRAINING
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2022to 7 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary Artery Bypass Graft, Aortic Valve Replacement, Mitral Valve Replacement having undergone one of these operations
- No Chronic Respiratory Disease
Who cannot join
- Aortic Valve Replacement and Mitral Valve Replacement performed together
- Use of a method other than median sternotomy
- Redo coronary bypass surgery
- Illiteracy and not knowing Turkish
- Being under psychiatric treatment and follow-up recently (last 1 year)
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted to understand how training given to patients before and after open-heart surgery affects their reactions during intubation (when a breathing tube is inserted), their agitation levels, and the time it takes to remove the breathing tube.
Study Design
Read more
The research followed a quasi-experimental design, meaning patients were divided into two groups:
Experimental Group - Received special training before and after surgery. Control Group - Received standard hospital care without additional training. Key Variables Independent Variable (What was changed): The training given before and after surgery.
Dependent Variables (What was measured):
Patient reactions during intubation Agitation levels Time taken to remove the breathing tube Study Hypotheses Patients who received the training would show different reactions compared to those who did not.
1.1. The trained group would show fewer negative reactions during intubation. Patients who received the training would have different agitation levels compared to the control group.
2.1. The trained group would be less agitated. The time taken to remove the breathing tube would be different between the two groups.
3.1. The trained group would have their breathing tube removed faster. Where and When Was the Study Conducted? The research took place at Bezmialem Vakif University Hospital in Istanbul in the cardiovascular surgery department, between October 10, 2022 - January 7, 2023.
Participants The study initially considered 123 patients who had undergone open-heart surgery during this period.
Patients were selected based on certain health conditions and criteria (age, no chronic respiratory disease, type of surgery, etc.).
After applying these criteria, 30 patients (15 in each group) were included in the final study.
How Were Patients Selected? To ensure fairness, patients were randomly assigned to either the experimental or control group.
A computer-generated random list was used to assign them. Who Was Included in the Study? Patients who had Coronary Artery Bypass (CABG), Aortic Valve Replacement (AVR), or Mitral Valve Replacement (MVR) surgery.
Patients aged 45-70 years old. Who Was Excluded? Patients with chronic respiratory disease (as it could affect intubation time). Patients who had previous open-heart surgery (as prior experience could influence their reaction).
Patients who did not speak Turkish or had cognitive issues. Patients with severe psychiatric conditions. Data Collection \& Training Process
Before the surgery:
Patients were asked about their age, gender, smoking habits, medical history, and other factors.
Their anxiety levels were measured using a scale from 0 to 10 (0 = No anxiety, 10 = Extreme anxiety).
Training for the experimental group:
A special 40-50 minute training session was given a day before surgery. The training included breathing techniques, relaxation methods, and information about what to expect during recovery.
Family members were also involved.
After the surgery:
Patients were sedated as part of hospital protocol and then observed when they first woke up in the Intensive Care Unit (ICU).
The trained group received additional therapeutic communication techniques when they first woke up to help them stay calm.
The control group received only standard hospital care. Four hours after waking up, all patients were evaluated for their agitation levels and reactions to intubation.
How Were Reactions Measured? Richmond Agitation Sedation Scale (RASS ) - This measured how restless or calm the patient was.
Observation of Intubation Reactions - The research team noted behaviors such as:
Trying to pull out the breathing tube Biting the tube Facial expressions (like frowning or grimacing) Grabbing bed sheets Moving legs restlessly Breathing in sync with the ventilator Each behavior was scored from 0 (Not observed) to 4 (Strongly observed). A higher score meant the patient was more uncomfortable with intubation.
Results General reactions to intubation (measured with a scale) were similar in both groups.
However, when specific behaviors were examined, the control group had more visible distress:
More frowning and wrinkled facial expressions (p=0.030). More grabbing of bed sheets (p=0.013). There was no significant difference in agitation levels between the two groups. The time taken to remove the breathing tube was also not significantly different between the two groups.
Conclusion The special pre- and post-surgery training helped patients remain more comfortable during intubation, reducing visible signs of distress.
However, the training did not significantly impact overall agitation levels or the time needed to remove the breathing tube.
This suggests that therapeutic communication techniques may improve patient comfort but do not necessarily speed up the recovery process.
- Conditions
- Cardiac Surgery Subjects, Nursing Care
- Being tested
- THERAPEUTIC APPROACH TRAINING
- Keywords
- Education,, Nursing, Cardiovascular Surgery, Therapeutic Approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERAPEUTIC APPROACH TRAININGBehavioural
This study focuses on pre- and post-operative training for open-heart surgery patients, aiming to reduce anxiety, agitation, and discomfort during intubation and recovery.
In the meeting phase, the nurse introduces herself, explains the research, and obtains written/verbal consent. The patient's anxiety level is assessed.
In the study phase, patients are informed about the surgical process, breathing exercises, Intensive Care Unit conditions, and postoperative care. They are encouraged to express fears and concerns to improve psychological preparedness.
Key topics include:
Fasting before surgery Breathing exercises to ease extubation Use of mechanical ventilation Intensive Care Unit environment \& pain management Early mobilization \& recovery timeline Patients receive guidance on their role in recovery, ensuring better adaptation and reduced distress post-surgery.
| Study group | Role | What they receive |
|---|---|---|
| Trained group | Experimental | Pre-Surgery:
Patients received a special training including therapeutic communication techniques.
The training was prepared by reviewing the literature and integrated into hospital practices.
One day before surgery, the patient and patient's relatives were trained in a session lasting 40-50 minutes.
All stages of the training were monitored using the "Preoperative Training Checklist ".
Postoperative:
When the patients were taken to the intensive care unit, sedation was applied again at the first awakening according to the hospital protocol.
After the effect of sedation wore off and the patient was conscious but still intubated, therapeutic interventions were performed.
This process was done with the "Postoperative Education Checklist " prepared based on the literature.
Data Collection:
4 hours after the patients woke up, by the researcher: RASS (Richmond Agitation Sedation Scale) was applied. Intubation Reactions Form was filled. The time to come out of intubation was recorded. Receives: Behavioral: THERAPEUTIC APPROACH TRAINING |
| Non-training group | No intervention | Preoperative No special training was given to the control group. Patients were only subjected to routine hospital procedures. Postoperative: Standard hospital protocol was applied when the patients were admitted to the intensive care unit. Sedation was applied again, but no additional therapeutic intervention was performed. Patients received only routine nursing care. Data Collection: 4 hours after patients woke up, by the investigator: RASS (Richmond Agitation Sedation Scale) was administered. Intubation Reactions Form was completed. The time to come out of intubation was recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic information form
The demographic characteristics of the patients such as age, gender, education level, chronic diseases, history of surgery, height and weight, smoking and alcohol use, psychiatric treatment and follow-up status were evaluated with a 13-item form created by the researchers by using the literature.
Measured: From the data obtained from the enrollment of the first participant until week 12 Before the operation
Numerical anxiety scale
The Numerical Anxiety scale has a starting point of "0" or "no anxiety" and an ending point of '10' or "severe anxiety" (horizontal line was used in this study). The patient chooses the number from the scale that best describes him/her. Preoperative and postoperative anxiety is higher in patients undergoing open heart surgery compared to other surgeries. Anxiety level is a factor that may lead to increased agitation and patient non-compliance with mechanical ventilator. For this reason, anxiety level was used as a control variable to measure the effectiveness of the intervention to be applied to the experimental and control groups and to ensure the homogeneity of the experimental and control groups. The results of the scale were evaluated on the arithmetic mean.
Measured: From the data obtained from the enrollment of the first participant until week 12 Before the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start10 Oct 2022
- Primary completion7 Jan 2023
- Study completion7 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgery SubjectsStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research is a quasi-experimental study with a post-test experimental-control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nareg Dogan, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881212
- Sponsor's protocol ID
- E-54022451-050.05.04-73654
- Status last verified
- Mar 2025
- First submitted
- 22 Jan 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I WANT TO PUBLISH IT AS AN ARTICLE IN A SCIE INDEXED JOURNAL
Publications
Tully PJ, Baker RA. Depression, anxiety, and cardiac morbidity outcomes after coronary artery bypass surgery: a contemporary and practical review. J Geriatr Cardiol. 2012 Jun;9(2):197-208. doi: 10.3724/SP.J.1263.2011.12221.
PubMed 22916068Hoyer J, Eifert GH, Einsle F, Zimmermann K, Krauss S, Knaut M, Matschke K, Kollner V. Heart-focused anxiety before and after cardiac surgery. J Psychosom Res. 2008 Mar;64(3):291-7. doi: 10.1016/j.jpsychores.2007.09.009.
PubMed 18291244İnce, F. (2020). Kardiyak cerrahi öncesi uygulanan eğitimin anksiyete, depresyon, yaşam kalitesi ve kinezyofobi üzerine etkisi (Master's thesis, İstanbul Medipol Üniversitesi Sağlık Bilimleri Enstitüsü).
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Therapeutic Approaches On Intubation Response, Agitation Behavior, And Extubation Time İn Patients Undergoing Open Heart Surgery
- ClinicalTrials.gov ID
- NCT06881212
- Acronym / sponsor ID
- E-54022451-050.05.04-73654
- Conditions
- Cardiac Surgery Subjects, Nursing Care
- Keywords
- Education,, Nursing, Cardiovascular Surgery, Therapeutic Approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 7 Jan 2023 (actual)
- Study completion
- 7 Jan 2023 (actual)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to understand how training given to patients before and after open-heart surgery affects their reactions during intubation (when a breathing tube is inserted), their agitation levels, and the time it takes to remove the breathing tube.
Study Design
The research followed a quasi-experimental design, meaning patients were divided into two groups:
Experimental Group - Received special training before and after surgery. Control Group - Received standard hospital care without additional training. Key Variables Independent Variable (What was changed): The training given before and after surgery.
Dependent Variables (What was measured):
Patient reactions during intubation Agitation levels Time taken to remove the breathing tube Study Hypotheses Patients who received the training would show different reactions compared to those who did not.
1.1. The trained group would show fewer negative reactions during intubation. Patients who received the training would have different agitation levels compared to the control group.
2.1. The trained group would be less agitated. The time taken to remove the breathing tube would be different between the two groups.
3.1. The trained group would have their breathing tube removed faster. Where and When Was the Study Conducted? The research took place at Bezmialem Vakif University Hospital in Istanbul in the cardiovascular surgery department, between October 10, 2022 - January 7, 2023.
Participants The study initially considered 123 patients who had undergone open-heart surgery during this period.
Patients were selected based on certain health conditions and criteria (age, no chronic respiratory disease, type of surgery, etc.).
After applying these criteria, 30 patients (15 in each group) were included in the final study.
How Were Patients Selected? To ensure fairness, patients were randomly assigned to either the experimental or control group.
A computer-generated random list was used to assign them. Who Was Included in the Study? Patients who had Coronary Artery Bypass (CABG), Aortic Valve Replacement (AVR), or Mitral Valve Replacement (MVR) surgery.
Patients aged 45-70 years old. Who Was Excluded? Patients with chronic respiratory disease (as it could affect intubation time). Patients who had previous open-heart surgery (as prior experience could influence their reaction).
Patients who did not speak Turkish or had cognitive issues. Patients with severe psychiatric conditions. Data Collection \& Training Process
Before the surgery:
Patients were asked about their age, gender, smoking habits, medical history, and other factors.
Their anxiety levels were measured using a scale from 0 to 10 (0 = No anxiety, 10 = Extreme anxiety).
Training for the experimental group:
A special 40-50 minute training session was given a day before surgery. The training included breathing techniques, relaxation methods, and information about what to expect during recovery.
Family members were also involved.
After the surgery:
Patients were sedated as part of hospital protocol and then observed when they first woke up in the Intensive Care Unit (ICU).
The trained group received additional therapeutic communication techniques when they first woke up to help them stay calm.
The control group received only standard hospital care. Four hours after waking up, all patients were evaluated for their agitation levels and reactions to intubation.
How Were Reactions Measured? Richmond Agitation Sedation Scale (RASS ) - This measured how restless or calm the patient was.
Observation of Intubation Reactions - The research team noted behaviors such as:
Trying to pull out the breathing tube Biting the tube Facial expressions (like frowning or grimacing) Grabbing bed sheets Moving legs restlessly Breathing in sync with the ventilator Each behavior was scored from 0 (Not observed) to 4 (Strongly observed). A higher score meant the patient was more uncomfortable with intubation.
Results General reactions to intubation (measured with a scale) were similar in both groups.
However, when specific behaviors were examined, the control group had more visible distress:
More frowning and wrinkled facial expressions (p=0.030). More grabbing of bed sheets (p=0.013). There was no significant difference in agitation levels between the two groups. The time taken to remove the breathing tube was also not significantly different between the two groups.
Conclusion The special pre- and post-surgery training helped patients remain more comfortable during intubation, reducing visible signs of distress.
However, the training did not significantly impact overall agitation levels or the time needed to remove the breathing tube.
This suggests that therapeutic communication techniques may improve patient comfort but do not necessarily speed up the recovery process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research is a quasi-experimental study with a post-test experimental-control group.
| Arm | Type | Receives |
|---|---|---|
| Trained group | Experimental | Behavioral: THERAPEUTIC APPROACH TRAININGPre-Surgery: Patients received a special training including therapeutic communication techniques. The training was prepared by reviewing the literature and integrated into hospital practices. One day before surgery, the patient and patient's relatives were trained in a session lasting 40-50 minutes. All stages of the training were monitored using the "Preoperative Training Checklist ". Postoperative: When the patients were taken to the intensive care unit, sedation was applied again at the first awakening according to the hospital protocol. After the effect of sedation wore off and the patient was conscious but still intubated, therapeutic interventions were performed. This process was done with the "Postoperative Education Checklist " prepared based on the literature. Data Collection: 4 hours after the patients woke up, by the researcher: RASS (Richmond Agitation Sedation Scale) was applied. Intubation Reactions Form was filled. The time to come out of intubation was recorded. |
| Non-training group | No intervention | –Preoperative No special training was given to the control group. Patients were only subjected to routine hospital procedures. Postoperative: Standard hospital protocol was applied when the patients were admitted to the intensive care unit. Sedation was applied again, but no additional therapeutic intervention was performed. Patients received only routine nursing care. Data Collection: 4 hours after patients woke up, by the investigator: RASS (Richmond Agitation Sedation Scale) was administered. Intubation Reactions Form was completed. The time to come out of intubation was recorded. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Coronary Artery Bypass Graft, Aortic Valve Replacement, Mitral Valve Replacement having undergone one of these operations
- No Chronic Respiratory Disease
Key exclusion criteria (5 listed)
- Aortic Valve Replacement and Mitral Valve Replacement performed together
- Use of a method other than median sternotomy
- Redo coronary bypass surgery
- Illiteracy and not knowing Turkish
- Being under psychiatric treatment and follow-up recently (last 1 year)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THERAPEUTIC APPROACH TRAININGThis study focuses on pre- and post-operative training for open-heart surgery patients, aiming to reduce anxiety, agitation, and discomfort during intubation and recovery. In the meeting phase, the nurse introduces herself, explains the research, and obtains written/verbal consent. The patient's anxiety level is assessed. In the study phase, patients are informed about the surgical process, breathing exercises, Intensive Care Unit conditions, and postoperative care. They are encouraged to express fears and concerns to improve psychological preparedness. Key topics include: Fasting before surgery Breathing exercises to ease extubation Use of mechanical ventilation Intensive Care Unit environment \& pain management Early mobilization \& recovery timeline Patients receive guidance on their role in recovery, ensuring better adaptation and reduced distress post-surgery. | Behavioural | Trained group |
Primary outcome
Sociodemographic information form
Time frame: From the data obtained from the enrollment of the first participant until week 12 Before the operation
The demographic characteristics of the patients such as age, gender, education level, chronic diseases, history of surgery, height and weight, smoking and alcohol use, psychiatric treatment and follow-up status were evaluated with a 13-item form created by the researchers by using the literature.
Numerical anxiety scale
Time frame: From the data obtained from the enrollment of the first participant until week 12 Before the operation
The Numerical Anxiety scale has a starting point of "0" or "no anxiety" and an ending point of '10' or "severe anxiety" (horizontal line was used in this study). The patient chooses the number from the scale that best describes him/her. Preoperative and postoperative anxiety is higher in patients undergoing open heart surgery compared to other surgeries. Anxiety level is a factor that may lead to increased agitation and patient non-compliance with mechanical ventilator. For this reason, anxiety level was used as a control variable to measure the effectiveness of the intervention to be applied to the experimental and control groups and to ensure the homogeneity of the experimental and control groups. The results of the scale were evaluated on the arithmetic mean.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 22916068Tully PJ, Baker RA. Depression, anxiety, and cardiac morbidity outcomes after coronary artery bypass surgery: a contemporary and practical review. J Geriatr Cardiol. 2012 Jun;9(2):197-208. doi: 10.3724/SP.J.1263.2011.12221.
- Background: PubMed 18291244Hoyer J, Eifert GH, Einsle F, Zimmermann K, Krauss S, Knaut M, Matschke K, Kollner V. Heart-focused anxiety before and after cardiac surgery. J Psychosom Res. 2008 Mar;64(3):291-7. doi: 10.1016/j.jpsychores.2007.09.009.
- Backgroundİnce, F. (2020). Kardiyak cerrahi öncesi uygulanan eğitimin anksiyete, depresyon, yaşam kalitesi ve kinezyofobi üzerine etkisi (Master's thesis, İstanbul Medipol Üniversitesi Sağlık Bilimleri Enstitüsü).
- Calculatorsoup.com. Random Number Generator. (2022) (Accessed: 16.08.2022).Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. I WANT TO PUBLISH IT AS AN ARTICLE IN A SCIE INDEXED JOURNAL
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THERAPEUTIC APPROACH TRAINING in people with Cardiac Surgery Subjects and Nursing Care, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sociodemographic information form (time frame: From the data obtained from the enrollment of the first participant until week 12 Before the operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06881212, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.